TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE

K083861 · Interacoustics AS · ETY · Apr 9, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K083861
• Device Name: TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE
• Applicant: Interacoustics AS
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Apr 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1090
• Device Class: Class 2

Intended Use

The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.

Device Story

Titan IMP440 is an electroacoustic impedance test instrument; comprises handheld Titan unit, Titan Cradle, Titan Shoulder Box, and Titan Suite PC software. Device generates controlled test tones and signals to perform tympanometry and acoustic reflex measurements. Used by clinicians in screening and diagnostic settings to evaluate hearing and diagnose otologic disorders. Measurements are controlled via the handheld unit; data can be processed or reviewed via PC software. Output assists healthcare providers in clinical decision-making regarding patient auditory health. System supports modular functionality via a license system.

Clinical Evidence

Bench testing only. Performance data confirmed the device meets all specified requirements and is substantially equivalent to the predicate device.

Technological Characteristics

Electroacoustic impedance test instrument; handheld form factor with cradle and shoulder box accessories. Features tympanometry and acoustic reflex measurement capabilities. Operates via a hardware platform (Titan Platform) with integrated PC software (Titan Suite/IMP440 module). Connectivity includes PC interface for data management. License-based functionality selection.

Indications for Use

Indicated for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders in patients requiring tympanometry and acoustic reflex testing.

Regulatory Classification

Identification

An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

Special Controls

*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Predicate Devices

• AT235 (K994254)

Submission Summary (Full Text)

{0}------------------------------------------------

Ko8 3861

Titan System 510k Notification :

.

APR 0 9 2009

Author Hanne Nielsen "

Image /page/0/Picture/4 description: The image shows the Interacoustics logo. The logo consists of the word "Interacoustics" in a bold, sans-serif font, enclosed within an oval shape. The oval shape is stylized to resemble a globe, with curved lines representing lines of latitude and longitude. The logo is black and white.

; }); Revision 1

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Titan

# SUBMITTER INFORMATION

| A | Company Name: | Interacoustics A/S |
|---|------------------------|--------------------------|
| B | Company Address: | Drejervaenget 8 |
| | | Assens, DK-5610, Denmark |
| C | Company Phone: | [phone] |
| C | Company Fax: | [phone] |
| D | Contact Person: | Hanne Nielsen |
| | | Quality Manager |
| | | Interacoustics A/S |
| E | Date Summary Prepared: | 04/11/2008 |

### DEVICE IDENTIFICATION

| A | Generic Device Name: | Tester, Auditory Impedance |
|---|----------------------------|-----------------------------------------------------------------------------------------------------------|
| B | Trade/proprietary<br>Name: | Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440,<br>Titan IMP440 Module, Titan Suite |

| C | Classification: | Class II | |
|---|-----------------|----------|--|
| D | Product Code: | ETY | |

Date 11/12/2008

{1}------------------------------------------------

Titan System 510k Notification

Author Hanne Nielser

Image /page/1/Picture/2 description: The image shows the Interacoustics logo. The logo consists of the word "Interacoustics" in a bold, sans-serif font, enclosed within an oval shape. The oval shape is formed by lines resembling the longitudes and latitudes of a globe. The logo is simple and clean, with a focus on the company name and a subtle representation of global reach.

Revision 1

#### SUBSTANTIAL EQUIVALENCE

| Predicate Device | Manufacture | 510(k) No. | Date Cleared |
|------------------|----------------|------------|--------------|
| AT235 | Interacoustics | K994254 | 14/03/2000 |

#### DEVICE DESCRIPTION

Product name: Titan IMP440

Titan IMP440 consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite and Titan IMP440 module). The measurements are controlled by the handheld unit. Titan IMP440 is going to be offered as 3 configurations that will support screening, diagnostic and clinic users. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system.

Titan IMP440 is an impedance product based on a hardware platform named Titan Platform. It uses a cabinet named Titan but may use any other cabinets as long as it meets the requirement of the platform. Other products will in the future be developed to the Titan platform and submitted as required and thereby become a part of the Titan System Family as Titan IMP440.

A connection box named Titan Shoulder Box enables different types of accessories to the hardware platform.

# INTENDED USE

The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.

#### TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Titan Impedance System and the predicate device has been performed. The results of this comparison demonstrate that the Titan Impedance System is equivalent to the marketed predicate device.

# PERFORMANCE DATA

The performance data indicated that the Titan Impedance System meets all specified requirements, and is substantially equivalent to the predicate device.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 0 9 2009

Interacoustics A/S Ms. Hanne Nielsen Quality manager Drejervaenget 8 Assens, DK-5610. Denmark

Re: K083861 Trade/Device Name: Titan IMP440 Regulation Number: 21 CFR 874.1090 Regulatory Class: Class II Product Code: ETY Dated: March 5, 2009 Received: March 9, 2009

Dear Ms. Nielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).

{3}------------------------------------------------

For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelston, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K083861

# Indications for Use

510(k) Number (if known): K083861

Device Name: Interacoustics A/S Titan IMP440

Indications for Use:

The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustics reflex.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

AZ

(Division, Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

KOR SAL 510(k) Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________